Transurethral Resection of Prostate SyndromeNCT03428451
Prophylaxis Versus Treatment for TURP Syndrome.
A study testing NaCl 3% HS and NaCl 0.9% NS in people with Transurethral Resection of Prostate Syndrome, run by Ahmed Mohamed ELbadawy at 1 site in Egypt.
Trial summary
This study is designed to investigate the usage \& effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Transurethral Resection of Prostate Syndrome
- What is being tested?
- NaCl 3% HS and NaCl 0.9% NS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I - III BPH patients
Who cannot join
- Patients having any condition contra-indicating regional anesthesia e.g impaired coagulation.
- Electrolyte imbalance,
- Uncontrolled hypertension,
- Congestive heart failure or being allergic to local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline
This study is designed to investigate the usage \& effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications
Read the detailed description
The study will be conducted on 60 patients ASA class I - III BPH patients, candidates for TURP surgery using monopolar electronic resectoscope. Eligible patients will be allocated into one of three study groups (n=20 in each). Group A patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr; Group B patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr; while Group C patients will receive NaCl 0.9% Normal Saline(NS) at a dose of 6 ml/kg/hr. All intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. Vital signs [mean BP, HR, CVP \& oxygen saturation (spO2)] will be recorded. Plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mOsm) will be measured. Incidence of TUR syndrome, need for ICU admission, post-operative ventilation and total hospital stay will be noted.
- Being tested
- NaCl 3% HS, NaCl 0.9% NS
- Keywords
- TURP, hypertonic saline, TURP syndrome, hyponatraemia
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 3% HSDrug
Also called Hypertonic saline
Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.
NaCl 3% HSDrug
Also called Hypertonic saline
Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.
NaCl 0.9% NSDrug
Also called Normal saline
Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Hypertonic saline ) | Active comparator | patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr. Receives: Drug: NaCl 3% HS |
| Group B (Hypertonic saline) | Active comparator | patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr. Receives: Drug: NaCl 3% HS |
| Group C (Normal saline) | Active comparator | patients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr. Receives: Drug: NaCl 0.9% NS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sodium level measured in mEq/L
Hyponatremia was defined as a serum sodium < 130 mEq/L
Measured: 72 hours
Secondary outcomes (2)
Incidence of TURP syndrome
Occurring TURP syndrome manifestations
Measured: 72 hours
Need for ICU admission
For cardio-pulmonary support(vasopressor,mechanical ventilation), neurological monitoring
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start10 Feb 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transurethral Resection of Prostate SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed ELbadawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mohamed ELbadawy, Kasr El Aini Hospital
- Investigators
- Ahmed ELbadawy, MD, Principal investigator, Faculty of medicine- Cairo University- Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428451
- Sponsor's protocol ID
- N02112
- Status last verified
- Dec 2018
- First submitted
- 26 Jan 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis Versus Treatment Against TURP Syndrome : Role of Hypertonic Saline
- ClinicalTrials.gov ID
- NCT03428451
- Acronym / sponsor ID
- N02112
- Keywords
- TURP, hypertonic saline, TURP syndrome, hyponatraemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahmed Mohamed ELbadawyUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the usage \& effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications
Detailed description
The study will be conducted on 60 patients ASA class I - III BPH patients, candidates for TURP surgery using monopolar electronic resectoscope. Eligible patients will be allocated into one of three study groups (n=20 in each). Group A patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr; Group B patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr; while Group C patients will receive NaCl 0.9% Normal Saline(NS) at a dose of 6 ml/kg/hr. All intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. Vital signs [mean BP, HR, CVP \& oxygen saturation (spO2)] will be recorded. Plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mOsm) will be measured. Incidence of TUR syndrome, need for ICU admission, post-operative ventilation and total hospital stay will be noted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Hypertonic saline ) | Active comparator | Drug: NaCl 3% HSpatients will receive NaCl 3% HS at a dose of 4 ml/kg/hr. |
| Group B (Hypertonic saline) | Active comparator | Drug: NaCl 3% HSpatients will receive NaCl 3% HS at a dose of 2 ml/kg/hr. |
| Group C (Normal saline) | Active comparator | Drug: NaCl 0.9% NSpatients will receive NaCl 0.9% NS at a dose of 6 ml/kg/hr. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA class I - III BPH patients
Key exclusion criteria (4 listed)
- Patients having any condition contra-indicating regional anesthesia e.g impaired coagulation.
- Electrolyte imbalance,
- Uncontrolled hypertension,
- Congestive heart failure or being allergic to local anesthetics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaCl 3% HSAlso: Hypertonic salineHypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma. | Drug | Group A (Hypertonic saline ) |
| NaCl 3% HSAlso: Hypertonic salineHypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma. | Drug | Group B (Hypertonic saline) |
| NaCl 0.9% NSAlso: Normal salineNormal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma. | Drug | Group C (Normal saline) |
Primary outcome
Serum sodium level measured in mEq/L
Time frame: 72 hours
Hyponatremia was defined as a serum sodium < 130 mEq/L
2 secondary outcomes
Incidence of TURP syndrome
Time frame: 72 hours
Need for ICU admission
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed ELbadawy, MD principal investigator
Faculty of medicine- Cairo University- Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaCl 3% HS and NaCl 0.9% NS in people with Transurethral Resection of Prostate Syndrome, run by Ahmed Mohamed ELbadawy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum sodium level measured in mEq/L (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.